Arakis Ltd v Meda Pharma GmbH & Co. KG
[2010] APO 26
•27 October 2010
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Arakis Ltd v Meda Pharma GmbH & Co. KG [2010] APO 26
Patent Applications 776913
Title:THE TREATMENT OF RESPIRATORY DISEASES
Patent Applicant: ARAKIS LTD
Opponent: MEDA PHARMA GMBH & CO. KG
Delegate: L. F. McCAFFERY
Decision Date: 27 October 2010
Hearing Date: 4 August 2010, in Canberra
Catchwords: PATENTS – opposition to grant– fair basis and priority date of the claims– claimed invention not foreshadowed in the priority document– novelty– essential features of the claims and inherency– no evidence that inhaled glycopyrrolate inherently provides a therapeutic effect for greater than 12 hours– disclosure of the individual components but no clear and unmistakable directions to the claimed invention– inventive step– matter of routine to prepare dry powder formulations comprising microparticles of glycopyrrolate and carrier particles providing a therapeutic effect for greater than 12 hours– no evidence that it was a matter of routine to formulate glycopyrrolate and a hydrophobic matrix material– full description– no evidence that the in vitro tests described are not indicative of the desired in vivo controlled release properties– manner of new manufacture– the specification discloses a new substance and not a mere collocation or mere working directions– opposition successful on the ground of lack of inventive step.
Representation: Patent applicant: Mr Paul Whenman, Mr Steven Gurney and Dr Jacqueline Warner of F B Rice & Co
Opponent:Mr Ben Fitzpatrick of Counsel instructed by Phillips Ormonde Fitzpatrick
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 776913
Title:THE TREATMENT OF RESPIRATORY DISEASES
Patent Applicant: ARAKIS LTD
Date of Decision: 27 October 2010
DECISION
Fair Basis. The claims are not fairly based on the priority document, GB 0008660.3. The claims therefore take the priority date of the date of filing of the complete application. As a consequence Keller is relevant prior art for the purposes of Section 7(3).
Novelty. The cited prior art documents do not disclose all of the essential features of the claims, or do not provide clear and unmistakable directions to the claimed invention. The claims are therefore novel.
Inventive step. It would be a matter of routine in view of Keller and the common general knowledge to prepare formulations as defined in Claims 1 to 5, 8 to 14 and 17 to 22. Claims 6, 7, 15, 16 and 23 to 25 are inventive since there is no evidence that establishes that it would be a matter of routine to prepare formulations comprising microparticles of glycopyrrolate in a hydrophobic matrix.
Other matters. The invention is fully described and is a manner of new manufacture.
Subject to an appeal to the Federal Court, applicant given 60 days to propose amendments that address the lack of inventive step.
Costs awarded against the applicant.
REASONS FOR DECISION
Patent application 89306/01 was filed under the PCT on 9 April 2001 by Arakis Ltd, claiming a priority date of 7 April 2000 from an earlier UK patent application (GB 0008660.3). The application was advertised accepted under serial number 776913 on 23 September 2004.
A notice of opposition to the grant of the patent was filed on 23 December 2004 by Viatris GmbH & Co KG, followed by a statement of grounds and particulars on 23 March 2005. An amendment under regulation 5.9 was allowed on 27 June 2005. An amendment under regulation 5.3B to change the name of the opponent to Meda Pharma GmbH & Co KG was allowed on 27 June 2005.
Evidence in Support was completed on 18 January 2006 and comprised the following declarations:
(a) Professor Peter Stewart dated 22 November 2005 and exhibits PJS-1 to PJS-8.
(b) Associate Professor Hak-Kim Chan and exhibits HKC-1 to HKC-11 (Chan #1).
(c) Associate Professor Chan and exhibits HKC-12 to HKC-22 (Chan #2).
Evidence in Answer was completed on 7 December 2006 and comprised the following declarations
(a) Professor John Seale dated 1 December 2006 and exhibits JPS-1 to JPS-3.
(b) Dr Susan Snape dated 9 November 2006 and exhibits SDS-1 to SDS-3.
Evidence in Reply was completed on 13 March 2009 and comprised the following declarations
(a) Professor David McKenzie dated 11 March 2009 and exhibits DM-1 to DM-7 (McKenzie #1).
(b) Professor McKenzie dated 11 March 2009 and exhibits DM-8 to DM-34 (McKenzie #2).
(c) Dr Gabriele Endler dated 10 March 2009 and exhibits GE-1 to GE-20.
(d) Ms Virginia Beniac-Brooks dated 10 March 2009 and exhibit VBB-1.
(e) Mr Raymond Evans dated 10 March 2009 and exhibit RLE-1.
Further evidence comprised a declaration dated 30 November 2009 by Ms Beniac-Brooks together with exhibits VBB-2 to VBB-7. Evidence in response comprised a declaration dated 26 February 2010 by Mr Damian Slizys together with exhibit G.
A request under s 104 to amend the accepted specification was filed on 9 June 2009. These amendments were allowed on 11 February 2010. On 21 July 2010 the applicant foreshadowed a request to further amend the specification, but noted that they did not wish to defer the hearing. The parties agreed to proceed with the hearing on the basis of the proposed amendments. A formal request to amend the specification was subsequently made on 5 August 2010.
The onus of proof in opposition proceedings lies with the opponent, who must establish that it is clear that a valid patent cannot be granted.[1] The opponent made submissions at hearing in relation to four grounds of invalidity:
(a) the invention so far as claimed in any claim is not novel according to s 18(1)(b)(i)
(b) the invention far as claimed in any claim does not involve an inventive step according to s 18(1)(b)(ii)
(c) the invention so far as claimed in any claim is not a manner of manufacture.
(d) the specification and claims do not comply with s 40.
[1] F. Hoffman-La Roche AG v New England Biolab Inc [2000] FCA 283.
Each of these grounds is considered in turn below.
The specification
10. Suitable routes of administration for the treatment of respiratory disease include injection, oral administration and inhalation.[2] Inhaler devices have apparently been used in Australia since the 1960’s and include nebulisers, metered-dose inhalers (MDI) and dry powder inhalers (DPI). [3]
[2] Stewart at paragraph 23, Chan #1 at paragraph 24.
[3] Stewart at paragraph 26, Chan #1 at paragraph 27.
11. The present invention is said to relate to the treatment of respiratory diseases by inhalation, and in particular to dry powder compositions comprising glycopyrrolate. The specification notes that glycopyrrolate is an antimuscarinic agent that has been used to reduce salivary secretions during anaesthesia and to reduce stomach acid secretion for the treatment of gastric ulcers. It has also been used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The specification further states that it is ‘desirable to develop an inhaled formula which is a potent, effective, long-acting bronchodilator for the treatment of respiratory disease, in particular COPD’. The compositions are intended to have duration of action greater than 12 hours, and most preferably greater than 20 hours.
12. To this end, formulation of glycopyrrolate in a hydrophobic matrix material as microparticles is preferred (page 5, lines 1 to 12). These are resistant to immediate dissolution on administration, but break down over time to release the glycopyrrolate. Magnesium stearate is particularly preferred as a matrix material as it has been approved for delivery via the lung. A single example of a composition of glycopyrrolate and magnesium stearate is provided.
13. The microparticles have a mass median aerodynamic diameter (MMAD) of less than 30 µm. These may be formulated with additional excipients to aid delivery and release. In particular, the inclusion of large carrier particles can aid the flow from the dry powder inhaler into the lungs. These include lactose particles having a MMAD of greater than 90 µm.
14. I note that the declarants differed as to what was considered a therapeutically effective bronchodilator response. The application states that a >10% increase in FEV1[4] is considered therapeutically effective (page 9). For the purposes of this decision I will take a therapeutic effect as at least requiring this level of bronchodilation.
[4] FEV1 is the volume of air that can be expelled from the lungs in one second from a full inhalation.
15. The specification as proposed to be amended comprises 25 claims. Claim 1 defines:
‘A medicament suitable for inhalation, for the treatment of a disease of the airways, wherein the medicament is a dry powder comprising glycopyrrolate in the form of microparticles that have a mass median aerodynamic diameter of less than 30 µm, and wherein the powder also comprises large carrier particles, and wherein the medicament is formulated so that one unit dose enables the glycopyrrolate to exert its pharmacological effect over a period of greater than 12 hours.’
16. Claims 2 to 9 are appended to Claim 1 and define various embodiments of the medicament. Notably, Claim 5 defines the large carrier particles to be lactose particles. Claim 6 defines the inclusion of a hydrophobic matrix material. Claim 7 further characterises the hydrophobic material as magnesium stearate.
17. Claim 10 defines an inhaler device comprising the medicament as claimed in Claim 1, further characterised by the inhaler being capable of delivering a unit dose of the powder comprising up to 5 mg glycopyrrolate. Claims 11 to 17 are appended to Claim 10 and define various embodiments analogously to Claims 2 to 9.
18. Claim 18 defines the use of glycopyrrolate for the manufacture of the medicament of Claims 1 to 9 for the treatment of a disease of the airways by dispensing a unit dose of the medicament comprising up to 5 mg glycopyrrolate from a dry powder inhaler. Claims 19 to 22 are appended to Claim 18 and further characterise the disease to be treated as asthma, cystic fibrosis, COPD and lung carcinoma associated with concomitant COPD respectively.
19. Claims 23 to 25 are omnibus claims which define medicaments, inhalers and uses with reference to the examples.
Fair basis and the priority date of the claims
20. The opponent submitted that the claims were not fairly based on the priority document and are only entitled to claim a priority date of the filing of the complete application (9 April 2001). This potentially impacts on the documents that may be considered for inventive step purposes.
21. Section 43(1) of the Act sets out that each claim of a specification must have a priority date. The action of section 43(2) and Regulation 3.12(1) provides that the priority date of a claim is the earlier of the date of filing of the specification or, where the claim is fairly based on matter disclosed in one or more priority documents, the date of filing of the priority document in which the matter was first disclosed.
22. The purpose of a provisional specification was summarised by Lockhart J[5] in the following way:
‘All that the provisional specification needs to do is to describe generally and fairly the nature of the invention, and not to enter into the minute details as to the manner in which the invention is to be carried out. It is a mode of protecting the inventor until the time of filing the final specification. It is not intended to be a complete description of the invention, but simply to disclose the invention fairly, though in rough state. The interval of time between the provisional and the final is intended to provide an opportunity for the development and precise expression of the invention foreshadowed in the provisional".
[5] Anaesthetic Supplies Pty Ltd v Rescare Ltd 28 IPR 383 at 401.
23. The test for determining the fair basis of a claim on a priority document is whether there is a real and reasonable disclosure of the claimed matter in the priority document.[6] In making such a consideration it is wrong to employ an over meticulous verbal analysis, or to proceed as if testing for infringement, isolate essential features of an invention disclosed in the provisional specification and ask whether they correspond to the essential features of the claim.[7] The provisional specification must be read as a whole.[8] These are the principles that I will apply here.
[6] CCOM Pty Ltd v Jiejing Pty Ltd 28 IPR 481 at 501.
[7] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd 62 IPR 461 at 479.
[8] Reference 5 at 402.
24. The priority document sets out that the ‘invention relates to the treatment of respiratory diseases’ and acknowledges that glycopyrrolate is an antimuscarinic agent that has been used in the treatment of airway diseases. In that context the applicant notes that ‘it is surprising that no glycopyrrolate formulation has been developed or registered for the treatment of airway disease’.
25. According to the summary of the invention, an object behind the invention is to develop an inhaled formulation which is a ‘potent, effective long-acting bronchodilator for the treatment of respiratory disease, in particular COPD’. The drug is intended for twice-daily dosing and most preferably once-daily dosing. I take this to mean that the formulation provides a therapeutic effect for at least 12 hours.
26. Conventional formulation technology may be used. In one embodiment the drug is present in both slow release and immediate release forms. In a further embodiment, the drug is delivered to both upper and lower airways affected by disease. The specification sets out that:
‘Dry powder inhalers, metered dose inhalers and nebulisers of various types are well known, as are suitable formulations of materials that allow the powder to be dispersed into the airways, on inhalation.’
27. I take this to mean that the invention is not intended to be limited to dry powder formulations, but rather to include other forms of inhalants. Reading the specification as a whole, I therefore consider that the invention described lies in the provision of inhalable controlled release formulations of glycopyrrolate for treatment of airway diseases.
28. The matter of the present claims therefore falls within the matter broadly described in the priority document. However the key question is whether there is a real and reasonable disclosure of the claimed matter. In this respect the only other specific mention in the priority document of dry powder formulations of glycopyrrolate is the following sentence:
‘Glycopyrrolate can be readily formulated as an inhalable dry powder, e.g. with one or more conventional additives such as carriers, excipients, surface active agents etc.’
29. This suggests that the invention may particularly be directed towards dry powder formulations comprising glycopyrrolate. However there is no specific disclosure or even general illustration of any dry powder formulations, let alone one comprising large carrier particles in combination with microparticles. While the priority document indicates that the formulations may be prepared by conventional techniques, there is nothing that clearly foreshadows the particular formulations defined by the present claims.
30. As a consequence I consider that the priority document does not provide a real and reasonable disclosure of the matter defined by the present claims and therefore the claims are not fairly based on the priority document. The priority date of the claims is therefore taken to be the date of filing of the complete application, namely 9 April 2001.
Novelty
31. The law on novelty is well established. The general test for novelty is the reverse infringement test,[9] which is satisfied if the alleged anticipation discloses all the essential features of the claimed invention.[10] The prior art must also provide clear and unmistakable directions to do what the patentee claims to have invented.[11] As noted in General Tire & Rubber:
‘To anticipate the patentees claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented… A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.’
[9] Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235.
[10] Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517.
[11] General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1972) RPC 457 at 486.
32. The opponent made submissions as to whether the invention constituted a valid selection from the prior art. The relevant law on selection patents is set out in Re: IG Farbenindustrie AG’s Patent as follows:[12]
‘Three general propositions may, however, I think be asserted as true: First, a selection patent to be valid must be based on some substantial advantage to be secured by the use of the selected members. (The phrase will be understood to include the case of a substantial disadvantage to be thereby avoided). Second, the whole of the selected members must possess the advantage in question. Third, the selection must be in respect of a quality of a special character which can fairly be said to be peculiar to the selected group’.
[12] Re: IG Farbenindustrie AG’s Patents (1930) 47 RPC 289, see also Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194.
33. These considerations will only apply where a citation discloses the essential features of the claim and there are clear and unmistakable directions to the invention. Once a citation meets these requirements then a consideration of whether the claims meet the three requirements of a valid selection patent will be undertaken.
34. The opponent relied upon three prior art documents under this ground of invalidity:
(a)David C. Schroeckenstein et al., Journal of Allergy and Clinical Immunology, Vol. 82 (1), 1998, pp. 115-119 (Schroeckenstein).
(b)US 5612053 (Baichwal)
(c)WO 2000/028979, corresponding to AU 756852 (Keller)
35. I will deal with each of these in turn. However, a matter for consideration before I turn to the citations is whether or not Schroeckenstein shows that glycopyrrolate inherently provides a 12 hour period of effect. This was a key point of discussion at hearing as the opponent relied on such inherency in support of their other novelty submissions. They referred to the evidence of Professor McKenzie,[13] who stated that:
‘Given that there was a greater than 12% increase in FEV1 at 12 hours, and that the rate of decline in the graph for the top three (3) doses is relatively slow, it seems obvious to me that the effect of the drug would continue beyond 12 hours.’
[13] McKenzie #2 at paragraph 14.
36. Assoc. Professor Chan provided similar evidence.[14] In contrast Professor Seale[15] believed that the results shown in Schroeckenstein did not support the conclusion that glycopyrrolate provided an effect for greater than 12 hours:
‘I believe that Figure 1 shows that the doses of 240, 480 and 960 µg are probably not significantly different from each other. In other words, the plateau of the dose-response curve has been reached before the top dose of 960 µg. In my view, Dr Chan’s conclusion of effectiveness beyond 12 hours is highly speculative as it was not measured. Schroeckenstein et al itself does not indicate that that (sic) the results shown therein establish bronchodilation beyond 12 hours.’
[14] Chan # 2 at paragraphs 50 to 54.
[15] Seale at paragraph 28.
37. Schroeckenstein discloses that the 240 and 480 µg dosage forms provide an approximately 15% increase in FEV1 at 12 hours, and I consider it a reasonable extrapolation that the FEV1 will remain above 10% beyond 12 hours. I am therefore satisfied that Schroeckenstein discloses MDI compositions that provide effective bronchodilation for greater than 12 hours.
38. However, there is no evidence before me that establishes that this property is inherent in any other inhalable formulations of glycopyrrolate, Indeed if the opponent’s submissions are correct, all inhalable formulations would be expected to provide a therapeutic effect for at least 12 hours. To the contrary, Schroeckenstein refers to an earlier study in which similar formulations of glycopyrrolate were found to provide effective bronchodilation for up to only 8 hours following administration (page 118, column 1, paragraph 1 which corresponds to HKC-16), and none of the declarants addressed the reasons for this difference. As a consequence I am unable to conclude that inhaled glycopyrrolate will inherently provide effective bronchodilation for a period greater than 12 hours in view of the results provided in Schroeckenstein.
The Schroeckenstein citation
39. Schroeckenstein describes a study of bronchodilation using a single administration of a glycopyrrolate aerosol. Bronchodilation was evaluated for dosages of 80, 240, 480 and 960 µg of glycopyrrolate over a period of 12 hours. No specific details of the components in the formulation are provided.
40. There was no dispute that Schroekenstein uses a MDI system rather than a dry powder, but the opponent submitted that DPI formulations were well known before the priority date, as were the use of large carrier particles in combination with active microparticles. They argued that if a disclosure is sufficient to describe the claimed product or process and enable it to be made without further inventive experiments it is immaterial that the particular product or process is not exemplified in the prior art document.[16]
[16] Smith Kline and French Laboratories Application [1968] RPC 415.
41. I do not consider this argument persuasive. The difference between the DPI and MDI formulations does not constitute mere missing information that the skilled addressee would add as a matter of course and without the application of inventive ingenuity or undue experimentation.[17] Rather, the inhalants used by Schroeckenstein constitute an entirely different system. Since Schroeckenstein does not teach a dry powder formulation it follows that the claims are novel in view of this citation.
The Baichwal citation
[17] Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134.
42. Baichwal discloses controlled release dry powder inhalants which use a controlled release carrier that comprises one or more polysaccharide gums of natural origin. The formulations are said to release the drug in vivo for a period of from about 1 to about 24 hours (column 4, lines 22 to 29). The average size of the microparticles is 0.1 to 10 microns for lung delivery and large carrier particles may be used (column 5, line 30 to column 6, line 43). Anticholinergics are a preferred class of drugs and glycopyrrolate is specifically named (column 10, line 11). The drugs preferably act locally on the pulmonary tissue and/or are absorbable from the respiratory tract (column 10, lines 3 to 8). The opponent argued that Baichwal therefore discloses all of the essential features of the present claims.
43. The applicant submitted that Baichwal merely provides a ‘shopping list’ of possible active agents, which besides glycopyrrolate includes such diverse actives as genes, gene fragments, polypeptides, proteins and enzymes. They submitted that the skilled person would be faced with the task of selecting glycopyrrolate out of a list of over 100 actives with no pointer to assist them, and would need to undertake a significant degree of non-routine experimentation in order to determine if a dry powder inhalant composition could be formulated and whether such a dry powder could exert a pharmacological effect over a period of greater than 12 hours.
44. I agree with this submission. There is nothing that would provide clear and unmistakable directions for the skilled person to select glycopyrrolate. Furthermore, even if glycopyrrolate was selected Baichwal states that the properties of the controlled release formulations will be dependent on the individual characteristics of the polysaccharide constituents (column 7, last paragraph). No guidance is provided as to how a particular combination of components may be selected to provide particular dissolution rates, and no evidence was adduced that would establish that the skilled person would determine such compositions without the need for further invention.
45. Furthermore, the opponent acknowledged that Baichwal did not provide any data as to the length of time that such a ‘hypothetical formulation’ of glycopyrrolate would provide a therapeutic effect. However, they argued that glycopyrrolate formulated as a liquid aerosol or dry powder would inherently provide an effect of greater than 12 hours based on the teaching of Schroekenstein. As I have noted above, I am not satisfied that the evidence establishes that dry powder formulations of glycopyrrolate will inherently provide an effect for greater than 12 hours.
46. Thus while Baichwal may broadly disclose each of the essential features of the claimed invention, I am not satisfied that it provides sufficiently clear and unmistakable directions to deprive the claims of novelty. I therefore consider that the claims are novel in view of Baichwal.
The Keller citation
47. The Keller citation was filed before, but published after, the purported priority date of the present claims. The parties did not dispute that the information relied upon by the opponent was contained in the specification at both its filing and publication dates. In any case this consideration is moot in view of my determination in relation to the priority date of the claims.
48. Keller relates to dry powder formulations for inhalation which comprise an inactive carrier of non-inhalable particle size and a finely divided pharmaceutically active agent of inhalable particle size. Magnesium stearate is used to improve the moisture-resistance of the compositions. A dry powder formulation comprising glycopyrrolate in combination with formoterol fumerate (a beta mimetic) is specifically disclosed in Example 8. The opponents asserted that this combination of actives would be recognised by the person skilled in the art (PSA) as being suitable for the treatment of respiratory diseases such as COPD and asthma. The formulation is prepared by screening and mixing formoterol fumarate, glycopyrrolate, magnesium stearate and lactoses in a tumble mixer. There is no disclosure that the composition disclosed in Keller has any controlled release properties.
49. I note that the example provided in the present specification is prepared by ball milling a mixture of micronised glycopyrrolate and magnesium stearate (75:25 by mass), wetting the mixture with cyclohexane and then drying. Presumably the wetting of the powder results in a product in which the magnesium stearate and glycopyrrolate physically combine to form the controlled release composite material (that is, the magnesium stearate forms a matrix for the active). Interestingly, Dr Snape provided evidence of a Phase 2 trial using a composition which she stated was also in accordance with the present claims. Dosages at 20, 125, 250 and 400 µg provided at least 14 hour therapeutic efficacy. The compositions were prepared by blending dry powder glycopyrrolate, magnesium stearate and lactoses in a high intensity mixer. I note that there is no apparent step given whereby magnesium stearate would associate with glycopyrrolate to act as a matrix material, and it not clear whether such an association occurs as a result of the high intensity mixing step. Prima facie, the magnesium stearate and glycopyrrolate remain as discrete particles and do not form a controlled release composite material. If the magnesium stearate and glycopyrrolate do not need to form a composite in order to provide the desired controlled release properties then the Keller formulation, which similarly is formulated as discrete particles, could inherently provide a therapeutic effect for greater than 12 hours. However no evidence was adduced on this point, and there is insufficient information before me about the respective processes and products to make a determination in this regard.[18]
[18] I note that Dr Snape’s evidence was the considered by the Delegate of the Commissioner in Arakis Ltd v Med Pharma GmbH & Co KG, [2008] APO 34. The opponent requested that the Commissioner serve a notice of production on Dr Snape for documents related to the experimental study. The information sought was not considered relevant by the Delegate. However, this evidence related to comparative studies on Schroeckenstein and not Keller.
50. I conclude that Keller does not disclose a controlled release formulation that provides a therapeutic effect for greater than 12 hours. The claims are therefore novel in view of this citation.
Selection
51. Neither Schroekenstein nor Keller discloses all of the essential features of the present claims. Even if Baichwal discloses all of the essential features of the present claims, I do not consider that there are clear and unmistakable directions to the present invention. Therefore, none of the documents raised by the opponent render the present claims lacking in novelty. As a consequence further consideration of whether the present invention constitutes a valid selection is unnecessary.
Inventive Step
52. The opponent made submissions in relation to obviousness in view of the common general knowledge alone, and in relation to the common general knowledge combined with certain documents under section 7(3).
53. Section 7 of the Act sets out that:
‘(2) For the purposes of this Act, an invention is taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to the person skilled in the art in light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).
(3) The information for the purposes of subsection (2) is;
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information;
being information that the skilled person… could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant and, in the case of information mentioned in paragraph (b), combined as mentioned in that paragraph.’
54. An appropriate test for inventive step is that set out in Wellcome Foundation[19] and approved by the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd:[20]
‘The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.’
[19] Wellcome Foundation Ltd v V. R. Laboratories (Aust.) Pty Ltd (1981) 148 CLR 262 at 286.
[20] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59.
55. The Full Federal Court (Apotex v Sanofi[21]) recently considered the starting point for the assessment of obviousness. The Full Court considered that the invention to be assessed for obviousness is ascertained from the patent. This analysis of the invention assists in determining the correct starting point for the application of the common general knowledge of the PSA in order to determine whether the invention as claimed was obvious.
[21] Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134 at 152 to 154.
56. The opponent submitted that the problem to be solved was that the therapeutic effect of glycopyrrolate in treating respiratory disease was too short. The applicant submitted that the problem relates to the treatment of respiratory diseases, and argued that the PSA would first need to determine that glycopyrrolate was suitable for the treatment of respiratory diseases.
57. As in Apotex v Sanofi, the opponent’s position presupposes that the PSA was in possession of the knowledge that glycopyrrolate could be used as an inhalant for the treatment of respiratory diseases. In contrast, the applicant’s position includes a consideration of whether or not the skilled person would possess the knowledge that glycopyrrolate is suitable as an inhalant for treating respiratory diseases. The key consideration is therefore whether the problem relates to the provision of a treatment for respiratory disease or to the provision of a controlled release formulation of glycopyrrolate.
58. The specification indicates that the invention relates to all muscarinic agents that normally exert their pharmacological effect over a period of less than 12 hours, with glycopyrrolate being a preferred agent (page 3, line 34 to page 3A line 2). However no other antimuscarinic agents are illustrated or exemplified. All discussion of the invention is in relation to a new formulation of glycopyrrolate rather than to the discovery of a new use of glycopyrrolate.
59. The background to the invention acknowledges that glycopyrrolate is known to have a significant effect on bronchodilation, and that ‘a number of studies have confirmed its potential utility’. The applicant acknowledges previous studies by Schroeckenstein, Skorodin,[22] and Walker,[23] each of which is said to disclose the treatment of respiratory diseases using glycopyrrolate with a duration of effective treatment of up to 12 hours (with 8 hours appearing to be maximal).
[22] M. S. Skorodin, ‘Pharmacotherapy for Asthma and Chronic Obstructive Pulmonary Disease. Current Thinking, Practices, and Controversies’, Arch. Intern. Med., 153(12), 1993, pp. 814-828. This was provided in evidence as DM-14.
[23] F. B. Walker et al., ‘Prolonged Effect of Inhaled Glycopyrrolate in Asthma’, Chest, 91(1), 1987, pp. 49-51. This was provided in evidence as HKC-16.
60. The specification states that in view of the prior art ‘it is surprising to find that no glycopyrrolate formulation has been developed or registered for the treatment of airway disease’. Since Schroeckenstein, Skorodin and Walker all disclose research studies on inhalable glycopyrrolate formulations and their use in respiratory diseases, I take this to mean that there was no treatment of airway diseases using glycopyrrolate in mainstream clinical use prior to 7 April 2000.
61. The specification further states that it is ‘desirable to develop an inhaled formula which is a potent, effective, long-acting bronchodilator for the treatment of respiratory disease, in particular COPD’. Release of the active agent is such that the initial peak of activity is reduced, which reduces the severity of side effects.
62. Given the discussion provided in the specification, and in particular the acknowledged prior art treatment of respiratory disease using glycopyrrolate, the problem does not appear to broadly lie in the treatment of respiratory diseases as suggested by the applicant. Furthermore, the invention is intended to provide greater than 12 hour therapeutic effect such that the formulation is suitable for once or twice-daily dosage. The prior art discloses formulations that are suitable for twice daily dosage up to 12-hourly treatment of respiratory diseases (see in particular Schroeckenstein). As a consequence I consider that the invention relates to providing an alternative controlled release glycopyrrolate formulation suitable for the treatment of respiratory diseases and having a duration of therapeutic effect of greater than 12 hours. I will take this as being the starting point for the inventive step assessment.
63. In view of the problem to be solved, I consider that the person skilled in the art would comprise a team of skilled persons with qualifications and experience in pharmaceutical chemistry, formulation, product development and manufacturing and clinical experience of the disease area, trials and treatment, particularly in relation to agents for the treatment of respiratory diseases.
Section 7(2) consideration: obviousness in view of the common general knowledge.
64. Suitable routes of administration for the treatment of respiratory disease include injection, oral administration and inhalation.[24] Administration of drugs by inhalation is attractive as it enables the drug to either exert a local effect or enter systemic circulation relatively quickly via the lungs. A relatively small dose can often achieve a therapeutic effect, and as a consequence side effects may be minimised.[25]
[24] Stewart #1 at paragraph 23, Chan #1 at paragraph 24.
[25] Stewart #1 at paragraph 26, Chan #1 at paragraph 27.
65. MDIs are small, portable devices that are conveniently carried by a user. A number of MDIs were commercially available in 2000, including the VentolinTM inhaler and the AtroventTM metered aerosol. MDIs typically consist of a pressurised aerosol canister containing a suspension or solution of the drug formulated in a propellant (generally a CFC). The patient operates the MDI to generate a mist and simultaneously inhales. These steps must be properly coordinated in order to receive the correct dosage. The use of a spacer attachment in the mouthpiece reduces the need to coordinate actuation and inhalation.[26]
[26] Chan #1 at paragraph 34.
66. DPIs are breath activated devices that contain micronised particles of a drug formulated in a fine powder form. Like MDIs, they are small and portable devices that are easy to use. The micronised drug is generally stored in a pre-filled capsule, blister or reservoir within the DPI. In use the capsule is ruptured by a pin which is actuated by a button, and the patient inhales the powder.[27] DPIs do not require the use of a propellant and the stability of the drug is often improved because it is not stored in solution.
[27] Chan #1 at paragraph 36.
67. By the late 1990s multi-dose DPIs such as the DPI Turbohaler were available. Professor McKenzie considered that this represented a great advance, providing good penetration of the drug into the lung without the need for good coordination or an additional spacer device. Professor McKenzie considered that DPIs were an obvious alternative and a ‘green’ solution to the CFC problem in MDIs.[28] Professor Seale acknowledged the difficulties patients experienced using MDIs but noted that a MDI may be preferred where the patient is unable to inhale sufficiently to actuate the DPI, for example in the case of a COPD patient.[29] Furthermore, concerns with the use of CFCs had been addressed by the development of non-CFC propellants.
[28] McKenzie #1 at paragraph 100.
[29] Seale at paragraph 19.
68. Professor Stewart stated that:
‘Little distinction is to be drawn between the use of MDI’s and DPI’s for the pulmonary delivery of a specific drug unless the physico-chemical or biological properties of the drug compel one choice over another…. I believe that little difference in efficacy or duration of action is observed when the same drug formulated (sic) for use in different inhaler systems. This is because the predominant factor that dictates drug efficacy is the pharmacological properties of the drug itself and not the pharmaceutical formulation or the device.
Absent any compelling evidence that a formulation for one device provides specific benefits over another, I would have expected that glycopyrrolate can be formulated as a MDI or a DPI’
69. His experience was in DPI formulation, and on that basis he preferred this form of administration.[30] Professor McKenzie and Assoc. Professor Chan considered that ease of use and the phasing out of CFCs had resulted in an increasing trend towards the use of DPIs for the delivery of aerosolised pharmaceuticals.[31] However, Professor Seale referred to an extract from JPS-3 which stated that ‘[m]etered dose inhalers are by far the most popular method for drug delivery’.[32]
[30] Stewart #1 at paragraph 61.
[31] Chan #1 at paragraph 38 and McKenzie #1 at paragraph 101.
[32] Seale at paragraph 20, and JPS-3 at page 200.
70. Professor Seale stated that a key consideration is the physicochemical characteristics of the drug.[33] Professor Stewart similarly stated that:
‘In deciding whether any particular administration route is to be used for a given pharmaceutical, regard would generally be had for the properties of the drug, such as the solubility and stability of the drug as well as any other physical, chemical and bulk properties of the drug. Marketing considerations and corporate expertise may also be taken into account.’[34]
[33] Seale at paragraph 17.
[34] Stewart #1 at paragraph 37.
71. For MDIs, the efficacy of a drug can be influenced by the compatibility of the drug with the propellant, whether it is in solution or in suspension, and the particle size of the drug emitted from the aerosol mist. In the case of DPIs, efficacy can be influenced by particulate interactions between the drug particles (including molecular, electrostatic and capillary actions), the nature of the carrier and the method used to prepare the powder mixture. Each of these factors also needs to be considered to determine whether a particular drug can be delivered in an appropriate formulation.[35]
[35] Stewart #1 at paragraphs 47 to 48.
72. In addition, Professor Stewart stated that there would be a number of ‘routine’ tests that would be needed in order to investigate the pulmonary administration of glycopyrrolate by DPI, including: determination of the fine particle fraction of the formulation using a cascade impactor; uniformity and repeatability of dose from the delivery system; assays for drug content and amount of drug delivered by the system; plume measurement; and stability trials to investigate the chemical and physical degradation of the drug and/or system.[36]
[36] Stewart #1 at paragraph 62.
73. The evidence suggests DPIs were receiving greater attention for the treatment of respiratory diseases. However, I do not take this to mean that they were the only choice and that no other delivery means would be considered by the PSA. Rather I consider that they were a viable alternative choice. The key consideration is whether the skilled person would formulate glycopyrrolate as a DPI as a matter of routine in view of the common general knowledge.
74. The selection of a particular administration route depends on the properties of the therapeutic agent. Professor Stewart stated that bulk, physicochemical and biological properties of a drug need to be considered, including water solubility, the size of the drug (or whether the drug is capable of being reduced in size if necessary), physical and chemical stability, whether the drug is capable of being formulated on a carrier system, and the compatibility of the drug with other components such as the solvent, surfactant and other pharmaceutical compounds.[37]
[37] Stewart #1 at paragraph 45.
75. No evidence was provided that clearly established the properties of glycopyrrolate would compel the PSA to formulate it as a DPI. Moreover, the evidence of Professor Stewart suggests that the PSA would be as likely as not to select glycopyrrolate for formulation as a DPI, and even if selected there would be a considerable amount of additional research and experimentation to determine whether glycopyrrolate was in fact suitable for use as a DPI. I consider these activities extend beyond matters of routine.
76. On balance I am not satisfied that the evidence shows that the PSA in April 2000 would as a matter of routine have formulated glycopyrrolate as a dry powder formulation. Accordingly I consider that the present claims are inventive in view of the common general knowledge alone.
Section 7(3) consideration: obviousness in view of a prior art document.
77. The opponent made submissions under this ground in relation to Baichwal and Keller. Keller was not published until after the priority date of the present application. However I have found that the complete specification is not fairly based on the priority document and accordingly the claims have a priority date of the date of filing of the complete application. Keller is therefore prior art for the purposes of inventive step under Section 7(3).
78. The initial consideration is whether the PSA would have ascertained, understood and regarded these documents as relevant. Professors McKenzie and Seale have wide ranging research and clinical interests in the area of respiratory disease, including asthma, and chronic airflow limitation. Both state that they regularly read articles in a range of journals but do not routinely read patent specifications.[38]
[38] McKenzie #2 at paragraph 126, Seale at paragraph 24.
79. Assoc. Professor Chan has research interests in the field of inhalable pharmaceuticals and dry powder aerosols.[39] He stated that he reads articles in range of journals as well as having regard to a number of standard textbooks.[40] In contrast to Professors McKenzie and Seale, he stated that in order to keep up with the latest developments he has regard to the patent literature as developments are often first reported there.[41] In support of this statement, he provided a copy of a review that he prepared in 2003 for the journal ‘Expert Opinion on Therapeutic Patents’.[42]
[39] Chan #1 at paragraph 7.
[40] Chan #1 at paragraphs 11 and 12.
[41] Chan #2 at paragraph 74.
[42] Exhibit HKC-21. I note that this was published after the priority date of the present application and is not otherwise relevant for the purposes of this opposition.
80. Clearly textbooks and journals are routinely consulted in the art. However there is a difference between the experts as to whether or not they routinely consult the patent literature. At hearing the opponent noted that Professors McKenzie and Seale were clinicians. Accordingly their interests would in the clinical trial stage, focussing on the administration of the drug, while formulators such as Assoc. Professor Chan would have regard to patent literature. I consider this a reasonable assumption. Given my interpretation of the skilled person as a team comprising clinicians, pharmaceutical chemists and formulators, I consider the skilled person would reasonably be expected to have regard to the patent literature.
81. The next consideration is whether the citations would have been ascertained and considered relevant in view of the problem- that is, would the PSA have ascertained these documents if seeking to provide an alternative controlled release glycopyrrolate formulation suitable for the treatment of respiratory diseases?
82. Baichwal and Keller both relate to dry powder formulations and accordingly are in the same field as the problem. They each describe inhalable formulations comprising agents that are suitable for treating respiratory diseases, and specifically name glycopyrrolate. Baichwal provides controlled release formulations, and as such is directly relevant to the problem. I therefore consider that the PSA would ascertain Baichwal and consider it to be relevant.
83. Keller provides a specific example of a formulation comprising glycopyrrolate, but does not relate to the provision of controlled release formulations. However, Professor Stewart and Assoc. Professor Chan stated that if they faced the task of developing a new treatment for respiratory disease they would have consulted standard reference materials to determine the bulk, physico-chemical and biological properties of glycopyrrolate. This would include a consideration of prior art delivery systems and clinical uses of glycopyrrolate.[43] As a consequence I am satisfied that the PSA would ascertain and consider Keller as relevant.
Obviousness in view of Baichwal
[43] Stewart #1, paragraphs 50 to 57 and Chan #1, paragraphs 48 to 58.
84. Baichwal teaches the use of polysaccharide gums to produce slow release formulations for inhalation which are said to provide release of an active agent for up to 24 hours. There is no specific disclosure of a formulation comprising glycopyrrolate or of formulations comprising microparticles together with large carrier particles.
85. Assoc. Professor Chan considered that he would have no difficulty in preparing a suitable glycopyrrolate formulation using the teaching of Baichwal.[44] In one embodiment, the compositions are prepared by granulating the active agent with the polysaccharide to provide particles of size from 2 to 10 microns, or alternatively by dissolving or dispersing the polysaccharide and active agent in a solvent, removing the solvent and milling or screening the composition to provide the desired particles. Assoc. Professor Chan considered that this process could be used with glycopyrrolate, which is soluble in water and alcohol. However he noted that conditions would need to be varied since glycopyrrolate may be hydrolysed under the aqueous conditions and higher pH used by Baichwal.
[44] Chan #2 at paragraph 34.
86. While glycopyrrolate is mentioned in Baichwal, this is as part of a large and diverse group of known pharmaceuticals. There is no further indication of any property that would make glycopyrrolate particularly suitable for formulation with these excipients. Furthermore, Baichwal sets out that:
‘The properties and characteristics of a specific controlled release carrier or excipient system prepared according to the present invention is dependent in part on the individual characteristics of the homo- and heteropolysaccharide constituents, in terms of polymer solubility, glass transition temperatures etc.’[45]
[45] Baichwal at column 7, lines 56 to 61.
87. Baichwal does not provide any specific discussion of the manner in which the individual polysaccharide components are selected in order to obtain particular properties and characteristics. Assoc. Professor Chan did not state whether he would select any particular combination to achieve the desired properties, or whether indeed all the polysaccharides disclosed by Baichwal would achieve the desired controlled release properties. While glycopyrrolate is mentioned, in the absence of evidence to the contrary I conclude that the PSA would need to determine the other components of the formulation in order to provide for once- or twice-daily administration. Prima facie it would not be a matter of routine to determine a suitable combination of polysaccharides that would interact with glycopyrrolate in such a way as to achieve the desired controlled release properties.
88. Accordingly I consider that the invention as claimed is inventive in view of Baichwal.
Obviousness in view of Keller
89. Keller discloses the use of preparation of dry powder formulations comprising microparticles of a therapeutic agent in combination with large carrier particles. Magnesium stearate is added to the compositions to improve their moisture resistance. Example 8 describes the formulation of glycopyrrolate with formoterol fumarate. The opponent noted that the formulation of glycopyrrolate with another bronchodilator made the formulation suitable for the treatment of respiratory diseases such as asthma and COPD.
90. The applicant submitted that Examples 1 to 7 of Keller provide details of the particle size and stability of the formulations comprising formoterol alone, but none are provided for Example 8. They argued that this suggested that the example was either prophetic or that the formulation does not work. I do not agree. Example 8 is carried out analogously to Example 4 and I take this to mean that the same conditions and carrier materials are used, and there is nothing in the specification to suggest that the formulation has not actually been prepared. Furthermore there was no evidence provided to show that the formulation does not work. On that basis I read Keller as providing a dry powder formulation comprising glycopyrrolate that may be used as an inhalant for the treatment of respiratory disease.
91. Keller discloses that glycopyrrolate is suitable for use as a DPI for the treatment of respiratory diseases, and microparticles may be used in combination with large carrier particles (including lactose). However, it does not disclose the formulation of glycopyrrolate as a controlled release dry powder providing a therapeutic effect for greater than 12 hours. The consideration here is whether it would be a matter of routine for the PSA to develop the controlled release formulation of the present claims in view of the teachings of Keller and the common general knowledge in the art.
92. While discussing the priority document, Assoc. Professor Chan stated that long-term effectiveness of medication for treatment of respiratory disease is merely a widely recognised and desirable property and anticholinergics such as glycopyrrolate were widely recognised for their long-term activity.[46] He noted that there were a number of long-lasting bronchodilators on the market, including salmeterol (12 hours), eformoterol (12 hours) and ipratropium bromide (6 hours).[47]
[46] Chan #2 at paragraph 68.
[47] Chan #1 at paragraph 40.
93. Professor McKenzie stated that if he had been faced with the task of developing a formulation that is both potent and effective for the treatment of respiratory diseases, he would have appreciated the advantage of using long acting bronchodilators such as an anticholinergic either alone or in combination with an inhaled corticosteroid. The selection of a long acting anticholinergic bronchodilator (such as tiotropium bromide or the like) was a ‘no brainer’ since it is more convenient to have a single daily dose than for the bronchodilator to be administered 4 to 6 times daily.[48] He further stated that:
‘In my opinion the literature available before April 2000 including the studies conducted by Walker et al and Schroeckenstein et al., showed that glycopyrrolate might well last for more than 12 hours without altering its formulation, so a controlled release form should not be necessary. Even if a controlled release formulation was considered necessary, it was not a new concept. Many oral medications… were available as controlled release formulations before April 2000… The use of controlled release formulations in inhaled therapies was also known before April 2000’.[49]
[48] McKenzie #1 at paragraph 103.
[49] McKenzie #2 at paragraph 38.
94. Professor McKenzie subsequently referred to Baichwal in support of this concluding statement, but I do not take this to mean that that Baichwal was the only known means of preparing controlled release formulations.
95. I am satisfied that controlled release dosage forms providing for once- or twice-daily dosing were a desired goal in the field of bronchodilators. This has not been disputed in the opposition, and the applicant’s submissions at hearing stated that once a day dosing is the desideratum of inhalable medicine. The evidence also indicates that it is routine in the art to prepare controlled release formulations. Indeed, the opposed specification states that conventional formulation technology may be used to achieve the controlled release composition (page 4, lines 6 to 11). As a consequence I consider that the skilled person would prepare controlled release DPI formulations having microparticles of glycopyrrolate in combination with large carrier particles and which provide a therapeutic effect for greater than 12 hours as a matter of routine in view of Keller and the common general knowledge as of April 2000. However, I do not consider that the evidence establishes that formulation of glycopyrrolate with a hydrophobic matrix material, and particularly magnesium stearate, would be a matter of routine.
96. In the present invention the hydrophobic matrix resists immediate dissolution on administration, but is broken down over time to release the glycopyrrolate. In contrast, Keller uses magnesium stearate to improve the moisture resistance of the DPI formulations. No evidence was adduced to establish that it was a matter of routine to use hydrophobic material as a controlled release matrix in inhalants. Accordingly I find the use of a hydrophobic matrix material (such as magnesium stearate) to be inventive.
97. In conclusion I find that Claims 1 to 5, 8 to 14 and 17 to 22 lack inventive step. However, Claims 6, 7, 15, 16 and 23 to 25 are inventive in view of Keller.
Full Description
98. The opponent argued that the specification does not fully describe the invention. In particular they submitted that the only exemplification in the specification (Example 1) is an in vitro test to determine the timing of the release of glycopyrrolate up to 100 minutes. No in vivo testing is provided to determine the effectiveness in the treatment of any respiratory diseases, and there is no testing to determine efficacy beyond 12 hours. The applicant submitted that the ‘best method of performance’ need not provide a specific exemplification of an invention, but simply enough instructions for the skilled person to put the invention into effect. They submitted that the specification when read as a whole provides enough instruction to enable the PSA to perform the invention. Furthermore they argued that the specification provides a working example outlining how to prepare the compositions of the invention and how to test the dissolution rate.
99. A claim is fully described if the disclosure enables the addressee to produce something within the scope of each claim without new inventions or additions or prolonged study of matters presenting initial difficulty.[50] The specification states that controlled release formulations will usually release 50% of the glycopyrrolate by dissolution in water over a period ‘greater than 10 minutes, preferably greater than 20 minutes and most preferably greater than 30 minutes’. During administration the glycopyrrolate may be released ‘over a period greater than 12 hours, preferably 15 hours, more preferably 20 hours’. I take this to mean that a composition having these in vitro dissolution rates in water will have the latter release properties in vivo. Professors Chan and McKenzie questioned the validity of this test and whether it showed that the compositions would be therapeutically effective for greater than 12 hours. However, no evidence was provided that enables me to conclude that the test described in the specification is not a technically sound means of assessing whether the formulation will provide the desired in vivo properties.
[50] Kimberley Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25].
As a consequence I consider that the invention as claimed is fully described.
Manner of Manufacture
In summary, the opponent’s arguments under this ground were:
The claims merely defined a known property of glycopyrrolate (that is that it exerts a therapeutic effect for greater than 12 hours) and therefore the invention lacked the necessary quality of inventiveness and the threshold requirement that there be a patentable invention. This argument was based on the properties and uses of glycopyrrolate being known from the prior art.
Claim 1 merely defines a collocation of known integers where each performs its own proper function independently of any of the others.
The dry powder medicament of Claim 1 merely amounted to no more than a working direction that would have been achieved by the PSA by trial and error or routine experimentation.
The Federal Court in Merck v Arrow[51] held that an invention related to a method of treating a disease using a drug that was already known for the particular treatment was not a manner of manufacture as the dosage regimen was known, albeit for the treatment of a different disorder, as was the advantage of reduced side effects through using such a regimen. They stated that:
‘[T]he patent specification discloses no new substance, no new characteristic of a known substance, no new use and no new method. There is, therefore, no manner of new manufacture.’
[51] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91.
Contrary to the opponent’s submissions, I consider that the formulation defined by Claim 1 (and subsequent claims) constitutes a new substance, and does not merely characterise the invention in terms of a known property of glycopyrrolate. No single document teaches all of the components of the formulation and as a consequence the substance cannot be considered as known. Furthermore, there is an interaction between the components of the formulation in that the large particles act to carry the microparticles into the respiratory tract and deliver them to the lower lung. On this basis I also consider than the claims constitute more than mere working instructions.
I therefore consider that the claims define a manner of new manufacture.
Conclusion
The opposition is successful on the ground of lack of inventive step in relation to Claims 1 to 5, 8 to 14 and 17 to 22. Under the rules of the Federal Court, parties will have 21 days from the date of this decision to file a notice of appeal with the Court. Subject to such an appeal being filed and given that there is patentable subject matter remaining in the application, I give the applicant 60 days to provide amendments to resolve the lack of inventive step.
Costs
Costs generally follow the event. I see no reason to depart from this practice. The opposition has been successful on the ground of lack of inventive step. Accordingly I award costs according to Schedule 8 against the applicant, Arakis Ltd.
L. F. McCaffery
Delegate of the Commissioner of Patents
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